A Phase 2, Multicenter, Randomized, Double-Blind, 52-week Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 606
- 试验地点
- 255
- 主要终点
- Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁)
研究概览
简要总结
The main purpose of this study is to assess if different dose levels of Brenipatide are safe and work the way they are intended to work in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), when compared with placebo. The study will last approximately one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD), at least 12 months prior to screening who meet the following criteria:
- •Current or former smokers with a smoking history of greater than or equal to (≥) 10 pack-years
- •Moderate-to-severe COPD (post-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁)/forced vital capacity (FVC) less than (<) 70 percent (%)
- •Modified Medical Research Council Dyspnea Scale (mMRC-DS) grade ≥2
- •Exacerbation history of ≥2 moderate or ≥1 severe exacerbations within the year prior to inclusion.
- •Background double therapy [long-acting β₂-agonists (LABA) + long-acting muscarinic antagonists (LAMA)] or triple therapy [inhaled corticosteroids (ICS) + LABA + LAMA)] for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to screening.
排除标准
- •Have a known pre-existing, clinically important lung condition other than COPD.
- •Have a current or recent acute, active infection before screening and up to randomization.
研究组 & 干预措施
Placebo
Placebo administered SC in combination with SOC.
干预措施: Standard of Care (Drug)
Brenipatide Dose 1
Brenipatide low dose administered subcutaneously (SC) in combination with Standard of Care (SOC).
干预措施: Brenipatide (Drug)
Brenipatide Dose 1
Brenipatide low dose administered subcutaneously (SC) in combination with Standard of Care (SOC).
干预措施: Standard of Care (Drug)
Brenipatide Dose 2
Brenipatide high dose administered SC in combination with SOC.
干预措施: Brenipatide (Drug)
Placebo
Placebo administered SC in combination with SOC.
干预措施: Placebo (Drug)
Brenipatide Dose 2
Brenipatide high dose administered SC in combination with SOC.
干预措施: Standard of Care (Drug)
结局指标
主要结局
Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁)
时间窗: Baseline through Week 36
次要结局
- Annualized Moderate or Severe COPD Exacerbation Rate Over 52 Weeks of Treatment(Baseline through Week 52)
- Change from Baseline in St. George's Respiratory Questionnaire for COPD (SGRQ-C) Total Score(Baseline, Week 36, and Week 52)
- Change from Baseline in Pre-BD FEV₁(Baseline through Week 52)